AEON Biopharma(AEON) - 2025 Q2 - Quarterly Results

Corporate Update and Business Overview AEON Biopharma reported Q2 2025 results, detailing ABP-450 biosimilar development and liquidity supporting operations through Q4 2025 - AEON Biopharma is developing ABP-450 (prabotulinumtoxinA) as a BOTOX (onabotulinumtoxinA) biosimilar, seeking accelerated and full-label U.S. market entry[1] - The U.S. therapeutic neurotoxin market exceeds $3.0 billion annually, presenting a major opportunity for biosimilar entry[2][7] Initial Announcement and CEO Commentary CEO Rob Bancroft highlighted strong progress for ABP-450 biosimilar development milestones in H2 2025 - CEO Rob Bancroft highlighted strong progress towards major biosimilar development milestones for ABP-450 in the second half of 2025[2] - Anticipated completion of primary structure analysis and select functional analyses in 3Q'25, critical for the planned Type 2a meeting with the FDA in 4Q'25[1][2] - AEON aims to bring ABP-450 to the U.S. market via the 351(k) pathway, potentially covering all BOTOX therapeutic indications and offering a more cost-effective solution[2] Recent Clinical and Corporate Highlights The company is advancing ABP-450 biosimilar development through comparative analytical assessment for FDA alignment - Advancing ABP-450's biosimilar development through the comparative analytical assessment (CAA) via a 351(k) regulatory pathway, using BOTOX as the reference product[3] - Expects to complete primary structure and select functional analyses for ABP-450 in 3Q'25[3] - Anticipates a Type 2a meeting with the FDA in 4Q'25 to discuss study results and align on next development steps[3] Liquidity and Capital Resources AEON Biopharma's cash and cash equivalents are expected to fund operations through Q4 2025 Liquidity and Capital Resources (June 30, 2025) | Metric | Amount | | :----- | :--------------------- | | Cash and cash equivalents | $8.4 million | - Cash runway expected to support operations through the fourth quarter of 2025 and the planned Type 2a meeting with the FDA[1][5] Expected Upcoming Milestones Key milestones include primary structure and functional analyses in Q3 2025, and an FDA meeting in Q4 2025 - 3Q'25: Expected completion of primary structure analysis by the Company[10] - 3Q'25: Expected completion of select functional analyses by Daewoong Pharmaceutical, the Company's licensing partner[10] - 4Q'25: Expected results and path forward from Biosimilar Biological Product Development (BPD) Type 2a FDA meeting[10] About AEON Biopharma AEON Biopharma develops ABP-450 as a BOTOX biosimilar for the U.S. market, manufactured by Daewoong - AEON Biopharma seeks accelerated and full-label access to the U.S. therapeutic neurotoxin market via biosimilarity to BOTOX[7] - ABP-450 is manufactured by Daewoong Pharmaceutical in compliance with current Good Manufacturing Practice (cGMP) in an FDA-approved facility[7] - The product is approved as a biosimilar in India, Mexico, and the Philippines. AEON has exclusive development and distribution rights for therapeutic indications of ABP-450 in the U.S., Canada, EU, UK, and other territories[7] Forward-Looking Statements This section outlines forward-looking statements, subject to risks and uncertainties, with no obligation to update - Forward-looking statements generally relate to future events or AEON's future financial or operating performance, including meetings with the FDA and the timing/outcome of primary comparative analytical studies[8] - Such statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially, including the completion of analyses, FDA meeting outcomes, future capital requirements, and regulatory factors[8][9][11] - Readers should not place undue reliance on forward-looking statements, which speak only as of the date they are made. AEON does not undertake any duty to update these statements[14] Contacts This section provides contact information for investor relations inquiries - Investor Contact: Laurence Watts, New Street Investor Relations, +1 619 916 7620, laurence@newstreetir.com[15] Condensed Consolidated Financial Statements Condensed consolidated financial statements detail AEON Biopharma's financial position and operating results for Q2 2025 and 2024 Condensed Consolidated Balance Sheets The balance sheets highlight significant increases in cash and total assets, alongside an improved stockholders' deficit Condensed Consolidated Balance Sheet Highlights (in thousands) | Item | June 30, 2025 | December 31, 2024 | Change | | :-------------------------------- | :------------ | :---------------- | :----- | | Cash and cash equivalents | $8,439 | $13 | +$8,426 | | Prepaid expenses and other current assets | $1,823 | $1,577 | +$246 | | Total current assets | $10,262 | $1,590 | +$8,672 | | Total assets | $11,662 | $3,142 | +$8,520 | | Total current liabilities | $9,129 | $14,149 | -$5,020 | | Convertible notes at fair value | $15,174 | $11,689 | +$3,485 | | Warrant liability | $2,122 | $1,187 | +$935 | | Contingent consideration liability | $69 | $3,541 | -$3,472 | | Total liabilities | $27,514 | $31,711 | -$4,197 | | Total stockholders' deficit | $(15,852) | $(28,569) | +$12,717 | - Cash and cash equivalents increased significantly from $13 thousand at December 31, 2024, to $8,439 thousand at June 30, 2025[17] - Total stockholders' deficit improved by $12,717 thousand, from $(28,569) thousand at December 31, 2024, to $(15,852) thousand at June 30, 2025[17] Condensed Consolidated Statements of Operations and Comprehensive (Loss) Income Statements of operations show a shift to net loss in Q2 2025, driven by fair value adjustments and reduced R&D expenses Condensed Consolidated Statements of Operations Highlights (in thousands, except per share data) | Item | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Selling, general and administrative | $3,258 | $3,321 | $6,383 | $7,970 | | Research and development | $1,064 | $4,439 | $1,889 | $10,172 | | Change in fair value of contingent consideration | $16 | $(161,233) | $(3,472) | $(97,464) | | Total operating costs and expenses | $4,338 | $(153,473) | $4,800 | $(79,322) | | (Loss) income from operations | $(4,338) | $153,473 | $(4,800) | $79,322 | | Change in fair value of convertible notes | $(1,854) | $1,795 | $(3,485) | $1,708 | | Change in fair value of warrants | $(542) | $5,905 | $86,187 | $(14,999) | | Loss on issuance of warrants | — | — | $(75,644) | — | | Net (loss) income | $(6,642) | $164,112 | $2,453 | $46,094 | | Basic net (loss) income per share | $(0.60) | $304.00 | $0.32 | $87.15 | | Diluted net (loss) income per share | $(0.60) | $304.00 | $0.31 | $87.15 | - Net loss of $(6,642) thousand for the three months ended June 30, 2025, compared to net income of $164,112 thousand for the same period in 2024[20] - Research and development expenses decreased significantly from $4,439 thousand in Q2 2024 to $1,064 thousand in Q2 2025[20] - The change in fair value of contingent consideration significantly impacted operating costs, moving from a $(161,233) thousand gain in Q2 2024 to a $16 thousand expense in Q2 2025[20]